Registration Dossier
Registration Dossier
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EC number: 639-655-8 | CAS number: 8016-38-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- Classification based on calculation rules for mixtures of the CLP regulation
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: accepted calculation method
Data source
Referenceopen allclose all
- Reference Type:
- other: Regulation
- Title:
- Regulation (EC) No 1272/2008 of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006
- Year:
- 2 008
- Bibliographic source:
- Regulation (EC) No 1272/2008 of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006
- Reference Type:
- other: Guidance
- Title:
- Guidance on the Application of the CLP Criteria - Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures - version 5.0
- Author:
- ECHA
- Year:
- 2 017
- Bibliographic source:
- ECHA-17-G-21-EN
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Classification based on calculation rules for mixtures of the CLP regulation
Test material
- Reference substance name:
- (R)-p-mentha-1,8-diene
- EC Number:
- 227-813-5
- EC Name:
- (R)-p-mentha-1,8-diene
- Cas Number:
- 5989-27-5
- Molecular formula:
- C10H16
- IUPAC Name:
- 4-isopropenyl-1-methylcyclohexene
- Reference substance name:
- Linalool
- EC Number:
- 201-134-4
- EC Name:
- Linalool
- Cas Number:
- 78-70-6
- Molecular formula:
- C10H18O
- IUPAC Name:
- 3,7-dimethylocta-1,6-dien-3-ol
- Reference substance name:
- Pin-2(10)-ene
- EC Number:
- 204-872-5
- EC Name:
- Pin-2(10)-ene
- Cas Number:
- 127-91-3
- Molecular formula:
- C10H16
- IUPAC Name:
- 6,6-dimethyl-2-methylenebicyclo[3.1.1]heptane
- Reference substance name:
- Linalyl acetate
- EC Number:
- 204-116-4
- EC Name:
- Linalyl acetate
- Cas Number:
- 115-95-7
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1,5-dimethyl-1-vinylhex-4-en-1-yl acetate
- Reference substance name:
- 3,7-dimethylocta-1,3,6-triene
- EC Number:
- 237-641-2
- EC Name:
- 3,7-dimethylocta-1,3,6-triene
- Cas Number:
- 13877-91-3
- Molecular formula:
- C10H16
- IUPAC Name:
- 3,7-dimethylocta-1,3,6-triene
- Reference substance name:
- p-menth-1-en-8-ol
- EC Number:
- 202-680-6
- EC Name:
- p-menth-1-en-8-ol
- Cas Number:
- 98-55-5
- Molecular formula:
- C10H18O
- IUPAC Name:
- p-menth-1-en-8-ol
- Reference substance name:
- 7-methyl-3-methyleneocta-1,6-diene
- EC Number:
- 204-622-5
- EC Name:
- 7-methyl-3-methyleneocta-1,6-diene
- Cas Number:
- 123-35-3
- Molecular formula:
- C10H16
- IUPAC Name:
- 7-methyl-3-methyleneocta-1,6-diene
- Reference substance name:
- Geranyl acetate
- EC Number:
- 203-341-5
- EC Name:
- Geranyl acetate
- Cas Number:
- 105-87-3
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 3,7-dimethylocta-2,6-dien-1-yl acetate
- Reference substance name:
- Geraniol
- EC Number:
- 203-377-1
- EC Name:
- Geraniol
- Cas Number:
- 106-24-1
- Molecular formula:
- C10H18O
- IUPAC Name:
- 3,7-dimethylocta-2,6-dien-1-ol
- Reference substance name:
- 3,7,11-trimethyldodeca-1,6,10-trien-3-ol,mixed isomers
- EC Number:
- 230-597-5
- EC Name:
- 3,7,11-trimethyldodeca-1,6,10-trien-3-ol,mixed isomers
- Cas Number:
- 7212-44-4
- Molecular formula:
- C15H26O
- IUPAC Name:
- 3,7,11-trimethyldodeca-1,6,10-trien-3-ol
- Reference substance name:
- Nerol
- EC Number:
- 203-378-7
- EC Name:
- Nerol
- Cas Number:
- 106-25-2
- Molecular formula:
- C10H18O
- IUPAC Name:
- 3,7-dimethylocta-2,6-dien-1-ol
- Reference substance name:
- Farnesol
- EC Number:
- 225-004-1
- EC Name:
- Farnesol
- Cas Number:
- 4602-84-0
- Molecular formula:
- C15H26O
- IUPAC Name:
- 3,7,11-trimethyldodeca-2,6,10-trien-1-ol
- Reference substance name:
- Neryl acetate
- EC Number:
- 205-459-2
- EC Name:
- Neryl acetate
- Cas Number:
- 141-12-8
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 3,7-dimethylocta-2,6-dien-1-yl acetate
- Reference substance name:
- Pin-2(3)-ene
- EC Number:
- 201-291-9
- EC Name:
- Pin-2(3)-ene
- Cas Number:
- 80-56-8
- Molecular formula:
- C10H16
- IUPAC Name:
- 2,6,6-trimethylbicyclo[3.1.1]hept-2-ene
- Reference substance name:
- Thuj-4(10)-ene
- EC Number:
- 222-212-4
- EC Name:
- Thuj-4(10)-ene
- Cas Number:
- 3387-41-5
- Molecular formula:
- C10H16
- IUPAC Name:
- 1-isopropyl-4-methylenebicyclo[3.1.0]hexane
- Reference substance name:
- Indole
- EC Number:
- 204-420-7
- EC Name:
- Indole
- Cas Number:
- 120-72-9
- Molecular formula:
- C8H7N
- IUPAC Name:
- 1H-indole
- Reference substance name:
- Methyl anthranilate
- EC Number:
- 205-132-4
- EC Name:
- Methyl anthranilate
- Cas Number:
- 134-20-3
- Molecular formula:
- C8H9NO2
- IUPAC Name:
- methyl 2-aminobenzoate
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Constituent 9
Constituent 10
Constituent 11
Constituent 12
Constituent 13
Constituent 14
Constituent 15
Constituent 16
Constituent 17
Results and discussion
In vitro / in chemico
Results
- Key result
- Parameter:
- other: Classification calculation
- Remarks on result:
- other: Skin sensitiser category 1
Any other information on results incl. tables
See attached document
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on the CLP classification rules, applicable for NCS, the Neroli oil (CAS 8016-38-4; List Nr 639-655-8) is classified for skin sensitization : Skin Sens.1 H317
- Executive summary:
The NCS is composed of several identified constituents and according to CLP articles 10 and 11, it can be treated as a mixture for classification purpose. The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2017) was used to determine the skin sensitising potential of the registered substance.
The registered substance has not been tested itself in appropriate and robust in vitro or in vivo tests, but one of its constituents is classified as Skin Sens.1 H317 (linalool) and is above the CLP generic concentration limit of 1% that triggers the classification of the mixture.
Therefore, the registered substance is classified for as a skin sensitiser category 1, according to the Regulation (EC) No 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
